Job Highlights
Not Disclosed
Entry level
Posted 1 year ago
Job details
The Position
The Regulatory Affairs Intern works collaboratively with the Regulatory Affairs team, internal networks (locally and globally), and Health Canada. This position provides an opportunity to support various types of regulatory applications, and to assist with departmental initiatives.
All Roche employees are required to report any information they become aware of related to the safety and / or quality of Roche products, within one business day of awareness. Adverse events should be reported to Roche Canada Patient Safety (Drug Safety) and product complaints to Roche Canada Medical Information. Employees involved in clinical trial oversight will follow SOPs for routing events appropriately.
Job Accountabilities:
Regulatory Submissions:
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.
As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.
Roche is an Equal Opportunity Employer.
The Regulatory Affairs Intern works collaboratively with the Regulatory Affairs team, internal networks (locally and globally), and Health Canada. This position provides an opportunity to support various types of regulatory applications, and to assist with departmental initiatives.
All Roche employees are required to report any information they become aware of related to the safety and / or quality of Roche products, within one business day of awareness. Adverse events should be reported to Roche Canada Patient Safety (Drug Safety) and product complaints to Roche Canada Medical Information. Employees involved in clinical trial oversight will follow SOPs for routing events appropriately.
Job Accountabilities:
Regulatory Submissions:
- Supports the Regulatory Affairs team in the preparation of various regulatory submissions to Health Canada (ie, Clinical Trial Applications and Amendments, Investigational Testing Authorizations, New Drug Submissions, Medical Device Applications, Supplemental New Drug Submissions, Notifiable Changes, and Level III Changes), and responses to Health Canada queries
- Responsible for actively participating in cross-functional meetings for regulatory submissions, working closely with relevant local and global stakeholders (Product Development Regulatory, Pharma Technical Regulatory, Product Development Operations, GxP, etc.)
- Accountable for keeping up-to-date with evolving Canadian Regulations to facilitate decision-making and ensure regulatory compliance
- Contributes to the development and maintenance of Canadian Standard Operating Procedures (SOPs), process maps, and operating guides that are aligned to our Canadian regulatory requirements (Food and Drug Act and Regulations; Medical Device Regulations)
- Maintains current knowledge on the relevant electronic document management systems used for regulatory projects to be able to efficiently execute day- to-day activities (eg. Regulatory Information Management System, Global Product Regulatory System, etc), and support cross-functional processes
- Active contributor to departmental regulatory information-sharing framework (gDrives, gSites, One Archive, etc.)
- Participation in departmental objectives pertaining to process optimization
- The following principles are prioritized within the team
- Offering help when you can; asking for help when you need it
- Being actively engaged with the Regulatory Affairs team - feeling comfortable speaking up, challenging when appropriate
- Working collaboratively and sharing expertise across the organization (locally and globally) to remove silos, duplication, ensuring efficient use of skills sets
- Must hold a Bachelor’s Degree in Science
- Must be currently enrolled in a post-graduate program in a relevant field (ie, Humber College’s Regulatory Affairs program; Seneca College’s Pharmaceutical Regulatory Affairs & Quality Operations program)
- Must be available to work full-time (35 hours per week) during 12 months
- Strong interpersonal and communication skills
- Strong problem-solving skills
- Strong project management and planning skills
- General understanding of Health Canada regulations and guidelines
- Microsoft Office and Google Suite skills are required
- This position is a 12-month work term (full-time) and will begin in May 2024
- This internship position is located in Mississauga.
- Our team follows a hybrid work structure (minimum 3 days per week in the office)
- Relocation benefits are not available for this job.
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.
As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.
Roche is an Equal Opportunity Employer.
Benefits Offered?
- No
Bonus Offered?
- No
Travel Required?
- No
Location:
- Canada
Experience:
- Entry level
Global Experience Needed?
- No
Specialized Experience Needed?
- No
Apply before:
- Apr 11, 2024
Company Overview
Roche
Current Openings: 0
Roche ist ein globales Unternehmen mit Vorreiterrolle in der Erforschung und Entwicklung von Medikamenten und Diagnostika und ist darauf fokussiert, Menschen durch wissenschaftlichen Fortschritt ein besseres, längeres Leben zu ermöglichen. Dank der Kombination von Pharma und Diagnostika unter einem Dach ist Roche führend in der personalisierten Medizin - einer Strategie mit dem Ziel, jeder Patientin und jedem Patienten die bestmögliche Behandlung zukommen zu lassen. Roche ist das grösste Biotech-Unternehmen weltweit mit differenzierten Medikamenten für die Onkologie, Immunologie, Infektionskrankheiten, Augenheilkunde und Erkrankungen des Zentralnervensystems. Roche ist auch der bedeutendste Anbieter von In-vitro-Diagnostika und gewebebasierten Krebstests und ein Pionier im Diabetesmanagement. Seit der Gründung im Jahr 1896 erforscht Roche bessere Wege, um Krankheiten zu verhindern, zu erkennen und zu behandeln und leistet einen nachhaltigen Beitrag zur gesellschaftlichen Entwicklung. Zum Ziel des Unternehmens gehört es durch Kooperationen mit allen relevanten Partnern den Zugang von Patienten zu medizinischen Innovationen zu verbessern. Auf der Liste der unentbehrlichen Arzneimittel der Weltgesundheitsorganisation stehen heute 30 von Roche entwickelte Medikamente, darunter lebensrettende Antibiotika, Malariamittel und Krebsmedikamente. Ausgezeichnet wurde Roche zudem bereits das neunte Jahr in Folge als das nachhaltigste Unternehmen innerhalb der Pharma-, Biotechnologie- und Life-Sciences-Branche im Dow Jones Sustainability Index. Die Roche-Gruppe mit Hauptsitz in Basel, Schweiz ist in über 100 Ländern tätig und beschäftigte 2017 weltweit rund 94 000 Mitarbeiterinnen und Mitarbeiter. Im Jahr 2017 investierte Roche CHF 10,4 Milliarden in Forschung und Entwicklung und erzielte einen Umsatz von CHF 53,3 Milliarden. Genentech in den USA gehört vollständig zur Roche-Gruppe. Roche ist Mehrheitsaktionär von Chugai Pharmaceutical, Japan. Weitere Informationen finden Sie unter www.roche.com/careers #Roche #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalizedHealthcare #GreatPlaceToWork #Innovation
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